SIGNA MAGNUS
GE Medical Systems, LLCSIGNA MAGNUS is a high-performance, head-only 3.0T magnetic resonance imaging (MRI) system designed to capture detailed images of the head, neck, TMJ, and limited cervical spine. It supports various imaging planes and advanced diffusion techniques to produce high-resolution images that assist physicians in diagnosis, helping improve patient care through better imaging quality and shorter scan times.
Intended Use
SIGNA MAGNUS is a head-only magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, diffusion-weighted imaging, and short scan times. It is intended to produce images and spectra of the head, neck, TMJ, and limited cervical spine for diagnostic purposes in patients 6 years and older.
Technology
The system uses a 3.0T magnet with an asymmetrically designed head-only gradient coil achieving up to 300 mT/m peak gradient amplitude and 750 T/m/s peak slew rate. It includes a dockable mobile patient table and supports a variety of pulse sequences and advanced diffusion imaging techniques, including Oscillating Diffusion Encoding (ODEN).
Performance
The device was tested according to international safety and performance standards (including IEC and ISO standards) and demonstrated biocompatibility and image quality performance equivalent to its predicate device SIGNA Premier (K193282). Clinical studies were not required, but sample images showed acceptable diagnostic quality per FDA guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/3/2024
5 months - 2
FDA Approval
10/17/2024
Other devices from GE Medical Systems, LLC
- Sonic DL2023 • 510K
- Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite2023 • 510K
- Auto Segmentation2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.